First-in-man Single-dose and Multiple Dose Study to Evaluate the Safety, Tolerability and Efficacy ofHY-133

NCT06290557 | Recruiting Phase 1 DMC

• 2 other identifiers: HY-1332023-507737-17-00
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

In this clinical trial we will test a new approach for decolonization of S. aureus. As innovative product HY-133 a recombinant chimeric bacteriophage endolysin will be sprayed in both nostrils of healthy subjects once or five times in one day. To avoid possible bias the subjects will be randomized 3:2 verum vs placebo, moreover the subject as well as the investigator will be blinded to the group assigned.

Conditions

Staphylococcus Aureus

Outcome Measures

Primary Outcomes (1)

• ADRs/AEs/SAEs occurring from the time of application until the final study visit (Day15) for each subject

  The primary objective of this trial is to evaluate the safety of the HY-133. Fort the primary objective the nature, frequency, and severity of AEs and/or SAEs occurring in the study are recorded as follows: ADRs/AEs/SAEs occurring from the time of application until the final study visit (D15) for each subject A DLT is defined as any AE of Grade 4 or above related to the IMP

  baseline, pre-intervention/procedure/surgery, up to Day15

Study Arms (2)

Verum

EXPERIMENTAL

Low Dose single application Low Dose multiple application High Dose single application high dose multiple application

Drug: HY_133

Placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

HY_133 DRUG

A recombinant chimeric bacteriophage endolysin HY-133

Verum

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be ≥ 18 years at the time of signing the informedconsent.
• Understand and voluntarily sign an informed consent document prior to any study related
• assessments/procedures.
• Nasal colonization with methicillin-susceptible S. aureus (MSSA)
• Female Subject of childbearing potential1 and male subjects with female partner of childbearing potential1 is willing to use highly effective contraceptive methods during treatment until end of study at D15

You may not qualify if:

• Nasal colonization with methicillin-resistant S. aureus (MRSA)
• Nasal traumata including nose penetrating foreign bodies (e.g. piercings)
• Presence of any significant morbidity, e.g. Diabetes, cardiovascular disease
• Acute or known chronic diseases of the nose or the paranasal sinuses
• Acute or known chronic diseases of other parts of the respiratory tract
• Running nose due to other reasons (e.g. allergic diseases)7. Positive serological HIV, hepatitis A, B or C test. In case of positive HBsAg, volunteer must provide prove of hepatitis B vaccination, otherwise volunteer must be excluded.
• Women during pregnancy and lactation.
• History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
• Participation in other clinical trials or observation period of competing trials, in the 12 weeks prior to screening.
• Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the Investigator based on medical history, physical exam, and/or laboratory screening test
• Systemic antibiotic treatment in the 12 weeks prior to screening.
• Intranasal eradication therapy in the 12 weeks prior to screening.

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (2)

Department of Dermatology, University Hospital Tuebingen

Tübingen, D-72075, Germany

RECRUITING

Department of Dermatology

Tübingen, Germany

RECRUITING

MeSH Terms

Conditions

Staphylococcal Infections

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Sebastian Volc, PD

CONTACT

07071 2926745; studienzentrum.immundermatologie@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 4, 2024
• Study Start: July 10, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

DE (2)